Chimeric Antigen Receptor T Cell Therapy Redirected to CD4 (CD4CAR)as a Second Line Treatment for Chronic Myelomonocytic Leukemia, CMML.
Trial Parameters
Brief Summary
This study is designed as a single arm open label traditional Phase I, 3+3, study of CD4-directed chimeric antigen receptor engineered T-cells (CD4CAR) in subjects with relapsed or refractory CMML. Specifically, the study will evaluate the safety and feasibility of CD4CAR T-cells.
Eligibility Criteria
Inclusion Criteria: 1. ≥ 18 years old at the time of informed consent 2. Ability to provide written informed consent and HIPAA authorization 3. Diagnosis of CMML that is CD4+ and is recurrent or refractory to first line standard of care treatment. 4. Creatinine clearance of ≥ 60 ml/min (or otherwise non clinically significant, per study investigator) 5. ALT/AST \< 3 x ULN 6. Bilirubin \< 2 x ULN 7. No supplemental oxygen at rest Note: Pulmonary Function Test (PFT) only required per treating physician discretion. 8. Adequate cardiac function with EF of ≥50%. This will not have to be repeated if within 45 days of initial assessment 9. Adequate venous access for apheresis and no other contraindications for leukapheresis Exclusion Criteria: 1. CD4 negative CMML 2. Pregnant or lactating women. The safety of this therapy on unborn children is not known. Female study participants of reproductive potential (see definition below) must have a negative serum or urine pregnancy test prior to initi